Recruiting

Cognitive Assessment

Sponsor:

The Neurology Center of Southern California

Code:

NCT07763392

Conditions

Cognition

Cognition Disorders

Cognition - Other

Dementia

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Voice-based Cognitive Testing

Study Details

Brief summary:

Trial weblink: https://www.memoryexam.com/job/norms/

Participants enrolled in this study will complete a single-session, non-invasive, computerized cognitive assessment administered through a secure, web-based digital platform. The purpose of the study is to establish normative cognitive performance data from healthy adults aged 18-100 years and develop age-, sex-, and education-adjusted reference values for the digital assessment platform. This is an observational study and does not involve any therapeutic intervention, investigational treatment, or alteration of routine medical care.

Following electronic informed consent, participants will complete a standardized screening questionnaire to determine eligibility. The questionnaire collects demographic information, education, English language proficiency, medical and neurological history, psychiatric history, medication use, substance use, sleep history, and self-reported cognitive concerns. Standardized mood screening instruments (PHQ-9 and GAD-7) are also administered. Individuals meeting predefined exclusion criteria that could significantly influence cognitive performance will not be included in the normative dataset.

Eligible participants will then complete a digital cognitive assessment battery using standardized visual and auditory instructions. The platform utilizes automated voice-recognition technology to capture spoken responses and standardized algorithms to score performance, eliminating the need for examiner scoring and ensuring consistent administration across participants. Total study participation, including consent, screening, and testing, is approximately 30 to 45 minutes.

The cognitive battery evaluates multiple cognitive domains commonly assessed during neuropsychological examinations. Language abilities are assessed through phonemic and semantic verbal fluency tasks, measuring the ability to rapidly generate words within specified categories. Confrontation naming is evaluated using digitally presented images that participants identify verbally. Learning and memory are assessed through immediate and delayed verbal recall tasks, including recognition memory measures. Attention and working memory are evaluated using forward and backward digit span tasks. Executive functioning and attention are further assessed using a brief computerized problem-solving task. Equivalent alternate versions of selected tasks may be administered to minimize practice effects while measuring the same cognitive domains. All assessments are brief, non-invasive, and completed using spoken responses.

The platform automatically records participant responses, response timing, and scoring metrics. Voice recordings are collected solely to support automated scoring and quality assurance. All electronic data are transmitted using encrypted connections and stored within HIPAA-aligned cloud infrastructure. Personally identifiable information is stored separately from cognitive performance data using unique study identification numbers, and only authorized study personnel have access to identifiable information. De-identified data will be used to generate normative reference values.

A subset of approximately 100 participants may be invited to complete a second assessment 2-4 weeks after the initial visit to evaluate test-retest reliability. Participation in this follow-up assessment is voluntary.

Participants will not receive diagnostic results or individualized interpretations of their performance because the study is intended solely to establish normative reference data. If responses on the PHQ-9 suggest potential acute self-harm risk, the platform will provide crisis resources and notify the study team in accordance with the study safety procedures.

The primary outcome of the study is the development of age-, sex-, and education-adjusted normative reference values for the digital cognitive assessment platform, supporting standardized interpretation of future assessments in clinical and research settings.

Conditions

Cognition

Cognition Disorders

Cognition - Other

Dementia

Alzheimer Disease

Study ID

NCT07763392

Start date

Mar 23, 2026

Status verified date

Aug, 2026

Completion date

Mar 23, 2027

Anticipated

Primary completion date

Oct 23, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adults aged 18 to 100 years at the time of enrollment.
  • Able to read, speak, and understand English sufficiently to complete all study procedures.
  • Able and willing to provide informed consent.
  • Adequate hearing, speech, and vision (with corrective devices if needed) to complete computerized voice-recognition cognitive testing.
  • Able to independently complete the digital cognitive assessment using a computer, tablet, or smartphone with internet access (or at a supervised study site if applicable).

Exclusion Criteria:

  • Known Cognitive Impairment Self-reported or previously diagnosed cognitive impairment, memory disorder, mild cognitive impairment, or dementia.
  • Neurological Disease or Brain Injury History of a neurological condition or brain injury that, in the opinion of the investigator, may adversely affect cognitive performance.
  • Psychiatric Illness Current or untreated psychiatric illness that may significantly influence cognitive testing performance.
  • Substance Use or Cognitive-Impacting Medications Current use of substances or medications known to significantly impair cognition or recent substance use that could affect test validity.
  • Sensory or Communication Limitations Inadequate English proficiency or speech, hearing, or visual impairments that would prevent valid completion of the digital cognitive assessment.
  • Functional or Medical Conditions Affecting Cognition Medical conditions or functional impairments that, in the opinion of the investigator, may interfere with accurate assessment of normal cognitive performance.
  • Investigator Discretion Any other condition or circumstance that, in the judgment of the Principal Investigator, would compromise participant safety, study compliance, or the validity of the normative dataset.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Ages 18-29

Ages 30-39

Ages 40-49

Ages 50-59

Ages 60-69

Ages 70-79

Ages 80-89

Ages 90-100

Interventions

Voice-based Cognitive Testing

Participants enrolled in this study will complete a non-invasive, computerized cognitive assessment administered through a secure, web-based digital platform. The purpose of the intervention is to collect normative cognitive performance data from healthy adults to establish age-, sex-, and education-adjusted reference values for the digital assessment platform. The study is observational in nature and does not involve any therapeutic intervention, treatment, or alteration of clinical care.

Following electronic informed consent, participants will complete a standardized eligibility screening questionnaire designed to identify factors that may influence cognitive performance and determine eligibility for inclusion in the normative dataset.

Eligible participants will then complete the digital cognitive assessment battery. The battery is administered entirely through the online platform using standardized visual and auditory instructions and automated voice-recognition technology.

Primary outcome measure

  • Development of normative reference values [ Time Frame: 30 minutes ]

Central Contacts and Locations

Central contacts

Locations

The Neurology Center of Southern California

Recruiting

Carlsbad, California, United States, 92011

More Information

Sponsor

The Neurology Center of Southern California

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • Memory
  • Cognition
  • Dementia
  • Alzheimer's Disease
  • Normal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Neurology Center of Southern California on 2026-08-17.